SIMVASTATIN tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Tillgänglig från:

American Health Packaging

INN (International namn):

SIMVASTATIN

Sammansättning:

SIMVASTATIN 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Simvastatin tablets USP are indicated: - To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. - As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). - In adults with primary hyperlipidemia. - In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). - As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). - As an adjunct to diet for the treatment of adults with: Primary dysbeta

Produktsammanfattning:

Simvastatin Tablets USP, 10 mg are peach colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C02' on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-511-01 Simvastatin Tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C03' on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-512-01 Simvastatin Tablets USP, 40 mg are brick red colored, round shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C04' on the other side. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-210-01 Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMVASTATIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SIMVASTATIN TABLETS.
SIMVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2, 2.3, 2.4)
                 3/2022
Warnings and Precautions (5.2)

5/2022
Warnings and Precautions (5.1, 5.3)       
              3/2022
Contraindications, Pregnancy and Lactation (4) Removed
           3/2022
INDICATIONS AND USAGE
Simvastatin tablets USP are an HMG-CoA reductase inhibitor indicated:
(1)
To reduce the risk of total mortality by reducing risk of coronary
heart disease death, non-fatal
myocardial infarction and stroke, and the need for coronary and
non-coronary revascularization
procedures in adults with established coronary heart disease,
cerebrovascular disease, peripheral
vascular disease, and/or diabetes, who are at high risk of coronary
heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol
(LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with
heterozygous familial
hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in
adults with homozygous familial
hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
DOSAGE AND ADMINISTRATION
_Important Dosage and Administration Information_: (2.1)
Take simvastatin tablets USP orally once daily in the evening.
Maximum recommended dosage is simvastatin tablets USP 40 mg once
daily. simvastatin tablets
USP 80 mg daily dosage is restricted to patients who have been taking
simvastatin tablets USP 80